Randomized Controlled Meditation Trial for Treating OCD

University of Sao Paulo

Status

Completed

Conditions

OCD

Treatments

Behavioral: Kundalini Yoga Meditation

Behavioral: Relaxation Response Meditation

Study type

Interventional

Funder types

Other

Identifiers

NCT01833442

Ipq0704/10br

Details and patient eligibility

About

The trial objective is to compare two very different meditation protocols (Kundalini Yoga and Relaxation Response meditation techniques) to help the OCD treatment.

Full description

The proposed trial comparing the two different meditation protocols is expected to have two phases: 0-month to 4.5-month period where we compare the Kundalini Yoga protocol with Relaxation Response meditation technique, both on the primary efficacy variable using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and some if not most of the secondary variables using The Dimensional Yale-Brown Obsessive Compulsive Scale (DY-BOCS), Clinical Global Impressions (CGI), Profile of Mood States (POMS), Beck Anxiety Inventory (Beck-A), Beck Depression Inventory (Beck-D), and SF-36 Health Status Questionnaire (SF36). Participants will go to the hospital once a week for a 1,5 hour meditation class.After 4.5-months, all patients will be evaluated and merged together into a single group. Patients will then receive 09 to 12 more months of the meditation protocol. The investigators are expecting to recruit 50 to 60 patients to start. Patients will be blinded to the content of the protocol in the other group at baseline and until one group shows greater efficacy on the primary efficacy variable. The intake physician will be blinded to the treatment groups of the patients.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of OCD for at least 6 months.
A minimum score of 16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) for the 10-item total score at the baseline screening will be required.
The patient must sign and been provided with a copy of an Assent Form for their reference.

Exclusion criteria

Psychoactive prescription medications other than those prescribed for OCD.
Spinal problems, or other physically limiting problems.
Clinical diagnosis of hypertension, or other cardiovascular problems.
Clinical diagnosis of Parkinson's disease.
Clinical diagnosis of major depressive disorder with psychotic features, schizophrenia, bipolar disorder, mental retardation, anorexia nervosa, bulimia nervosa, autistic disorder, Asperger's disorder and other forms of pervasive developmental disorder, or traumatic brain.
Clinical diagnosis of Tourette's Syndrome.
Patients without regular and reliable transportation to the study site.
Patients who choose not to participate in meditation and/or chanting (out loud or silently) for personal or religious reasons.